Official recall notice

FDA DeviceClass IINotable

FDA Recall: Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC

Recall date
2026-04-08
FDA class
Class II

Why it was recalled

Hazard

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Product description

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Verify with the official notice →
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